Primary outcome is to assess HRQoL in high risk and advanced melanoma patients treated with immune checkpoint-inhibitors. Secondary outcomes are to describe anxiety and depression; fear of cancer recurrence; melanoma-specific HRQoL; symptoms and…
ID
Source
Brief title
Condition
- Other condition
- Skin neoplasms malignant and unspecified
Synonym
Health condition
Kwaliteit van leven
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is to assess HRQoL. This will be assessed with The European
Organization for Research and Treatment of Cancer Quality of Life
Questionnaire-Core 30 (EORTC QLQ-C30).
Secondary outcome
Secondary outcomes are collected through different questionnaires:
sociodemographic questions, the Functional Assessment of Cancer Therapy -
Melanoma (FACT-M), the Hospital Anxiety and Depression Scale (HADS), the Cancer
Worry Scale (CWS), the immunotherapy-specific questtionaire, 4 questions about
sexual health (EORTC sexuality module), the work-ability index (WAI)
questionnaire, the 5-level EuroQoL-5D (EQ-5D-5L) and patients' perceptions of
received information (QLQ-INFO25).
Background summary
Still little is known about the long term effect of the different
immunotherapies on psychosocial outcomes in high risk melanoma and advanced
melanoma survivors. Collecting patient-reported outcomes (PROs) and
health-related quality of life (HRQoL) data is important for understanding the
short term and long term impact of melanoma itself and the treatment with ICIs
on quality of life outcomes in melanoma patients. Therefore, in this study we
want to do more research into patient reported outcomes, what is necessary to
identify personal care needs and contribute to the development of appropriate
supportive care to optimize melanoma patients* wellbeing and HRQoL.
Study objective
Primary outcome is to assess HRQoL in high risk and advanced melanoma patients
treated with immune checkpoint-inhibitors. Secondary outcomes are to describe
anxiety and depression; fear of cancer recurrence; melanoma-specific HRQoL;
symptoms and work ability in high risk and advanced melanoma patients treated
with immune checkpoint-inhibitors.
Study design
This is a prospectively enrolling, monocenter cohort study in melanoma patients
eligible for undergoing ICI treatment. Study outcomes will be obtained via PRO
questionnaires, to identify the short term (during treatment) and long term
impact of melanoma itself and the treatment with ICIs on quality of life
outcomes in melanoma patients outside clinical trial context. All PRO
questionnaires will be combined into one set and administered (digitally
through the local hospital platform or on paper) on several times (11 times in
total) during a total follow-up of 5 years. Clinical data will be combined with
the questionnaire results.
Study burden and risks
The burden for filling in each questionnaires will be maximum 30 minutes. This
will be done 11 times over 60 months. The total burden for the patient over 5
years is 330 minutes (5.5 hours). There are no risks associated with
participation, nor are there any additional benefits.
Plesmanlaan 121
Amsterdam 1066 CX
NL
Plesmanlaan 121
Amsterdam 1066 CX
NL
Listed location countries
Age
Inclusion criteria
Adults of 18 years and older; Melanoma patients indicated to receive treatment
with immune checkpoint-inhibitors, according to the clinical guidelines;
Written informed consent to participate in the study.
Exclusion criteria
Insufficient understanding of the Dutch or English language; Inclusion in
experimental clinical trials
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75996.031.20 |